Status:
TERMINATED
Evaluation of the TriActiv ProGuard System During Carotid Artery Stenting
Lead Sponsor:
Kensey Nash Corporation
Conditions:
Carotid Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of the TriActiv® ProGuard™ System when used during a stent placement in a blockage within the carotid artery in patients considered to ...
Detailed Description
Patients with certain anatomic or medical conditions have a greater risk of serious complications following carotid endarterectomy (a surgical procedure that removes blockages in the carotid artery). ...
Eligibility Criteria
Inclusion
- Greater than 18 year of age
- Patient gives informed consent
- Less than 30mm stenosis in the common and/or internal carotid artery: at least a 50% stenosis if symptomatic or at least an 80% stenosis if asymptomatic
- At least one medical or anatomic condition which makes the patient a high surgical risk.
Exclusion
- Stroke within 14 days
- Major stroke with significant residual effects
- Myocardial infarction within 72 hours
- Extensive atherosclerotic disease in the aortic arch or proximal common carotid artery
- Severe carotid artery tortuosity
- Total occlusion
- Presence of thrombus or heavy calcification in the carotid artery
- Pre-existing carotid artery dissection
- Any planned interventional or surgical procedures within 30 days
- Atrial fibrillation
- Creatinine \> 2 mg/dL
- Current participation in another investigational drug or device study
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2007
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00395785
Start Date
November 1 2006
End Date
June 1 2007
Last Update
July 25 2007
Active Locations (34)
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1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294-0012
2
Thomas Hospital
Fairhope, Alabama, United States, 36532
3
Brotman Medical Center
Beverly Hills, California, United States, 90210
4
Good Samaritan Hospital
Los Angeles, California, United States, 90017